Compliance Zen

February SmarterCompliance Published

The February issue of my FDA newsletter SmarterCompliance has been published.  Contents include:

• Challenges in Choosing an Auditor
• Designing a Records Management Training Program
• Drug and Biotech Warning Letter Trends
• Three Threshold Part 11 and Record Archiving Questions
• Managing Project Risk Proactively
• Featured Reading:  The Imposter

Downloads for subscribers include:

• EMA Site Master File guidance
• FDA guidance on using bayesian statistics in clinical trials
• FDA guidance on proprietary drug name submissions
• FDA guidance on cGMP dissolution calibration
• Article on reimbursement considerations for device firms in preclinical
• Article on 28 points to consider to protect clinical trial patient privacy

Also, don't forget - if you pre-order a copy of my new book, Get to Market Now!  Turn FDA Compliance into a Competitive Edge, you can save 32% at Barnes & Noble.  The book will be on bookstore shelves on May 1.

CMOs and Records Risks

After a couple of different pharmaceutical firms received complete response letters from the FDA over the past few months, the editors at Contract Pharma asked me to write some general advice on how pharma firms that use contracted services like manufacturers and clinical sites can avoid running risks stemming from the contracted service and poor records management controls.

You can see my article here:

http://www.contractpharma.com/expertsopinion/2010/02/12/cmos_and_complete_response_letters

In summary, it's been my experience that firms really have two choices, neither of which is particularly easy or 100% perfect:

1.       Write a contract that specifically spells out how your CMO is to retain records, what records it is to retain, what oversight and reviews of records your CMO is to conduct, by whom, how often, and so on – in other words, require in the contract that the CMO implement all the aspects of what you believe go into a good records retention program for FDA compliance – and then audit that regularly with dedicated records review due diligence; OR

2.       Expect your CMO to already have an FDA-compliant records management program in place and conduct your on-site due diligence and quality system audits to verify compliance with this as it relates to records relevant to your product and company.

You can get some good advice along with insights into building your own FDA records control programs by taking a look at my recorded seminar on records retention and management for FDA compliance.  If you need outside help, consider my private FDA records consulting service.

When it comes to managing critical suppliers' records, if you've got a more ideas than the two I've listed above, I'd love to hear it.  Just bear in mind - coming up with good compliance ideas is easy; coming up with enforceable good compliance ideas is definitely a bit more challenging.

Pre-Order My New Book at Barnes & Noble

My publisher just notified me that Barnes & Noble has posted the pre-order page of my new book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine.

You can save about $20 pre-ordering it now through the above link to Barnes & Noble.  As soon as the pre-order is available through Amazon.com, I'll post that as well.

And the dedicated book website will be available to everyone in May with the book's publication; current subscribers to my FDA newsletter SmarterCompliance will get earlier access to all the templates and downloads.

For now, if you've any questions, please feel free to let me know!

Reimbursement: Plan Early

In an interview I did with Clinica in the UK (which they turned into an article "Device Reimbursement: Plan Early, Says US Compliance Consultant"), I made the case that firms need to incorporate reimbursement evaluation and assessments as early as possible, preferably toward the end of the preclinical stage.

Some points from the article:

• The sooner you can evaluate reimbursement potential, the better your return on investment in clinical trials
• Try to build a reimbursement evaluation into the stage gate review process for moving a new medicine from preclinical to clinical
• Early reimbursement evaluation allows you to determine what potential customers (prospective patients, physicians, hospital administrators, etc.) will need to see when it comes to efficacy and safety claims
• Early reimbursement evaluation gives you the time to better shape your marketing messages to different customers
• Early reimbursement offers you the chance to set better cost controls for production and the rest of development; it will hardly benefit you as the company if you are making a product that costs you more than you will earn back in reimbursement

Key tactics to help incorporate reimbursement planning early in development include stage gates, regulatory affairs road-mapping, and clinical regulatory strategic plans, all of which I discuss in detail in my forthcoming book, Get to Market Now!

Bringing in reimbursement considerations as early as possible in development help demonstrate an integrated, holistic compliance and development strategy - and show how compliance departments such as regulatory affairs and quality management drive value to a company's bottom line.  And that's what I call Lean Compliance.

Are you ready?